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SArcopenia Prevalence in Frail Older Adults. SAF Study

SArcopenia Prevalence in Frail Older Adults: SAF Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02903992
Acronym
SAF
Enrollment
225
Registered
2016-09-16
Start date
2016-05-01
Completion date
2019-12-31
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Frail Elderly, sarcopenia

Brief summary

The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable. This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (\<0.789 men and \<0.512 women) was found to be associated with increased likelihood for mobility impairment. In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.

Interventions

Patients with at least one Fried criteria will have a Dual-energy X-ray absorptiometry (DXA) to measure lean muscle mass adjusted for body mass index. As part of the usual care in the Frailty Clinic patients will also have a clinical examination, a standard biological sample (requiring 15 ml of blood); an evaluation of the cognitive and functional performances, of their medico-economic situation and lifestyle.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 70 years and over, * Living independently (ADL score ≥ 5/6), * Fail or pre-frail according to Fried criteria, * Informed written consent, * Subjects affiliated to a social security.

Exclusion criteria

* Robusts patients (no Fried criteria), * Other disorders that could interfere with the interpretation of the study (like visual or hearing impairments), * Subjects under justice protection, * Participation in another study at the same time.

Design outcomes

Primary

MeasureTime frameDescription
Sarcopenia Diagnostic with Dual-energy X-ray absorptiometryone day (participation of subject)The primary outcome of SAF study is to assess the prevalence of sarcopenia in frail and pre-frail older adults. The primary endpoint is the sarcopenia diagnostic. In patients with at least one Fried criteria, we would like to detect the number of patient with low lean muscle mass adjusted for body mass index \<0.789 for men and \<0.512 for women.

Secondary

MeasureTime frameDescription
(SPPB) scoreone day (participation of subject)Short Physical Performance Battery (SPPB) score
(MMSE) scoreone day (participation of subject)Mini-Mental State Examination (MMSE) score
(MNA) scoreone day (participation of subject)Mini Nutritional Assessment (MNA) score
(IADL) scoreone day (participation of subject)Instrumental Activities of Daily Living (IADL) score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026